DeviceClearance

Product code PGW— Neurology

Acclarent ENT Navigation System

Classification name
Ear, Nose, And Throat Stereotaxic Instrument
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Total cleared
38
First cleared
Most recent

FDA classification definition

“Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.”

— U.S. Food and Drug Administration, device classification record for product code PGW under 21 CFR 882.4560, via openFDA

Market context for product code PGW

FDA has cleared 38 devices under product code PGW between 2014 and 2026, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PGW

Adverse events under product code PGW

product code PGW
Malfunction
1,199
Total
1,199

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PGW

Data sourced from openFDA. This site is unofficial and independent of the FDA.